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Test Code Chlam by NAAT Chlamydia trachomatis by Nucleic Acid

Useful For

The APTIMA COMBO 2 Assay is a target amplification nucleic acid probe test that utilizes target capture for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease.

Patient Preparation

No special patient preparation required

Special Collection Instructions

Swab specimens must be submitted with the correct swab provided in the APTIMA collection kit. Instructions for collection are provided on the kit packaging.
Urine specimens must be aliquotted in to APTIMA transport media within 24 hours of collection.

Collection Method

  • Clinician collected endocervical, vaginal and male urogenital swabs.
  • Self-collect swabs using the APTIMA vaginal self collect kit.
  • Urine specimens.
  • Clinician collected gynecological specimens collected into PreserveCyt solution.
  • Clinician collected eye swabs, cornea scrapings, rectal swabs and throat swabs placed in transport media.

Minimum Volume

  • 1 APTIMA swab specimen
  • 2 mL of urine
  • 2 mL PreserveCyt solution
  • 2mL M4 transport media with swab.

Container

For endocervical and urethral specimens collect APTIMA Swab:


For throat, eye, and rectal sources collect sterile rayon swab in BD Universal Transport Media:
 

Preferred Specimen

  • Urine
  • Cervix
  • Vaginal
  • Urethral
  • Penile
  • Endocervical

Acceptable Specimens

  • Urine
  • Cervix
  • Vaginal
  • Urethral
  • Penile
  • Eye
  • Lesion
  • Rectal
  • Throat

Reference or Target Ranges

Negative

Reportable Units

Positive/Negative

Critical Value

Not defined for this assay

Reasons for Rejection

Hemolysis Threshold N/A
Icterus Threshold N/A
Lipemia Threshold N/A
Interfering Subtances/Other If the lab receives an APTIMA swab specimen transport tube with no swab, two swabs, a cleaning swab, or a swab not supplied by Gen-Probe, the specimen must be rejected.
If urine specimens are not aliquotted into the APTIMA transport media within 24 hours of collection, the specimen must be rejected.
Swab specimens collected in any media other than APTIMA transport media or M4/Viral Transport Media may be rejected.

Specimen Stability

Ambient APTIMA swabs: 60 Days

Raw urine specimens: 24 Hours

Processed urine specimens: 30 Days

Viral Media specimens: See Note
Refrigerated (4°C to 8°C) APTIMA swabs: 60 Days

Raw urine specimens: 24 Hours

Processed urine specimens: 30 Days

Viral Media specimens: See Note
Frozen(-70°C to 0°C) APTIMA Swabs: 12 Months

Raw urine specimens: N/A

Processed Urine specimens: 90 Days

Viral Media specimens: See Note


Note regarding specimens in viral transport media:
Specimens received in M4 and M4RT intended for GC and/or CT testing should be stored and transported at 2°C to 30°C for up to 24 hours. Specimens that will not arrive in the laboratory within 24 hours should be stored at -20°C to 8°C. Mix specimens well by vortexing and transfer 1mL of the M4 or M4RT media into the APTIMA specimen transfer tube. Once the specimen is transferred to the APTIMA Specimen Transfer tube, the specimen must be assayed with the APTIMA COMBO 2 Assay within 30 days when stored at 2°C to 8°C or 14 days when stored at 15°C to 30°C. If longer storage is needed, freeze at -20°C to -70°C for up to 12 months after transfer.

Performance Information

Days and Time Performed Daily Monday – Friday
Expected Turn Around Time 1 -3 days on receipt in lab
Stat Availabilty No
Performing Bench Molecular Pathology
Methodology/Method Description Hologic Panther – Nucleic Acid Amplification

Special Handling

Refrigerate urine prior to aliquotting.

Additional Information/Important Notes

  1. The effects of tampon use, douching, and specimen collection variables have not been assessed for their impact on the detection of CT or GC.
  2. The presence of mucus in endocervical specimens does not interfere with the detection of CT or GC by the APTIMA COMBO 2 Assay. However, to ensure collection of cells infected with CT, columnar epithelial cells lining the endocervix should be sampled. If excess mucus is not removed, sampling of these cells is not ensured.
  3. Therapeutic failure or success cannot be determined with the APTIMA COMBO 2 Assay since nucleic acid may persist following appropriate antimicrobial therapy.
  4. Results from the APTIMA COMBO 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to theclinician.
  5. A negative result does not preclude a possible infection because results are dependent on adequate specimen collection.

CPT Codes

87491